The construction and significance of medical laboratory quality management system
Introduction: With the rapid development of science and technology, clinical laboratory testing instruments and methods have made revolutionary progress, and the service object? Clinical care and patient satisfaction did not therefore have a fundamental change. Here is what I bring you the construction and significance of the quality management system of the medical laboratory, I hope it will help you.
This allows test workers to begin to think and seek a scientific management method to continuously improve the quality of laboratory test results to meet the increasing demand of customers. International Organization for Standards (International Organization for Standards, ISO), the College of American Pathologists (College of American Pathologists, CAP) and other international standards continue to come into our field of vision, in particular, the Health Planning Commission on June 1, 2006, officially promulgated the Measures for the Administration of Clinical Laboratories in Medical Institutions, which clearly defines a medical laboratory as ? A laboratory that conducts hematology, biology, chemistry, microbiology, biophysics, immunology, hematology-immunology, cytology and other tests on a variety of specimens taken from the human body and provides medical testing services for the clinic? Article 20 of which provides? Clinical laboratories of medical institutions should provide interpretation of clinical test results and consulting services? This shift has changed the positioning and concept of medical laboratories [1], but also makes the clinical laboratory managers began to use a systematic view of the results of clinical testing quality assurance measures and develop a holistic solution. Regardless of the choice of standards, or to meet the basic requirements of the "management of clinical laboratories in medical institutions," the first must establish a comprehensive quality management system? that is, the core of test quality assurance, and effective operation and continuous improvement. Medical laboratory quality management system construction has been implemented for many years in the international arena, through practice has proved that it plays a very positive role in standardizing laboratory management, guaranteeing the quality of test results, and improving the quality of personnel [2]. For the medical laboratory quality management status quo, to solve the problems in quality management, to guide the medical laboratory more systematic and scientific quality management, in order to achieve the promotion of the quality of service continues to improve, enhance the core competitiveness of the medical laboratory purpose [3-4].
First, the establishment of the quality management system of medical laboratories
The establishment of the quality management system of medical laboratories should be based on a serious investigation and careful analysis of the status quo of their own laboratories. Through investigation and analysis, systematically sort out the problems and deficiencies in laboratory management and technology. After investigation and analysis, the establishment of quality management system should also pay attention to: whether it is in line with the selected standards, whether it is in line with laws and regulations, whether it is suitable for the work of medical laboratories and so on [5-6], do not copy, copy other laboratories.
1. Construction principles: medical laboratory quality management system needs to follow certain principles to establish. These principles mainly include: (1) the principle of service-oriented; (2) the principle of full participation; (3) the principle of full control; (4) the principle of continuous improvement; (5) the principle of unity of quality and effectiveness [7]. Follow these principles of quality management system construction, can greatly mobilize the enthusiasm and initiative of all staff, in the establishment of the system at the beginning of the conformity, appropriateness and effectiveness of the system to lay a solid foundation.
2. planning and design: for medical laboratories, quality management system is a new thing, both managers and staff lack of experience in the establishment of quality management system, therefore, the establishment of the quality management system at the beginning of the planning and design is particularly important. In the planning and design phase should be completed: (1) full education and training; (2) determine the quality policy and quality objectives; (3) clear organizational structure and job setup; (4) determine the allocation of resources. Good planning is the key to the success of the quality management system construction, planning stage of the work completed the better, the later the system construction and operation of the encountered difficulties will be less.
3. Writing system documents: medical laboratory quality management system is a documented management system, medical laboratory policies, processes, plans, procedures and standard operating procedures should be documented. Documentation is the basis for action of all personnel in the medical laboratory, the implementation of the document is easy to get and can fully understand the documents used, the medical laboratory management to ensure that these documents are easy to understand and implement, the document should be passed on to the relevant personnel. Medical laboratory quality management system documents mainly include: quality manual (first level, programmatic documents), procedural documents (second level documents, supportive documents), standard operating procedures, records, etc. (third level documents, implementation documents) [8]. The writing of the system documents must be full participation, according to the actual situation of the laboratory in accordance with the relevant norms, rigid? Fetishism? Seemingly quickly completed the writing of the document, but for the future implementation of a number of obstacles.
Second, the operation of the quality management system of medical laboratories
The operation of the quality management system of medical laboratories should follow the requirements of the quality management system documents, in accordance with the contents of the document to start the system of operation of the work. Usually a trial run for a period of time, through internal monitoring and auditing to test the establishment of the quality management system to achieve the desired purpose [9].
1. Personnel training and education: all staff of the medical laboratory for the quality management system knowledge and all relevant content of the system document training. Let each staff member of the quality management system concept, purpose, method, based on the principles and standards have a full understanding, and then recognize the medical laboratory quality management status quo and the gap between the advanced management model, recognize the establishment of a quality management system for the center of the significance of quality management. Training for all levels and types of personnel should be developed detailed training plan, strict implementation of the plan to complete the established training content. After the end of the training, strict assessment will be carried out, and those who fail in the assessment will be re-trained and assessed until they meet the requirements or have their positions adjusted. Through rigorous and serious training and assessment, to unify the staff's ideological understanding, mobilize the staff's enthusiasm and initiative, standardize their work behavior has played an obvious role in promoting.
2. System operation management: medical laboratory quality management system operation focuses on element management. To comprehensively manage all the elements of the quality management system, the various management positions should be set up in accordance with the requirements of the job responsibilities of the management of the various elements to ensure that the requirements of the elements are fully implemented. Clear job descriptions and responsibilities of the content and the full authorization of the higher management is the basis for good management of the elements; full of documents to learn, strict implementation of the system documents is to do a good job of the elements of the management of the security.
Medical laboratory quality management system operation of the difficulties in process management. The workflow specified in the system document must be strictly implemented to ensure the effectiveness of the system operation. Functional management work is responsible for the specific implementation of the system process management, is the hub of the system operation, closely linked to the decision-making level and the implementation of the layer, bear the top and bottom, to ensure that the system workflow in line with the requirements of the system documents. Medical laboratory to establish an internal quality control system to monitor? The entire testing process? and eliminate the causes of nonconformity and dissatisfaction in all stages of the quality chain in order to meet the quality requirements of the organization itself and those it serves, and to ensure that test results meet the expected quality standards. The control system should provide staff with clear and easy to understand information, based on which anyone can make technical and medical decisions to eliminate errors in the test process before, during and after the test[10]
3. System operation supervision and inspection: supervision and inspection is to ensure that the quality management system of medical laboratories to ensure the effective operation of the necessary measures. In the establishment of the quality management system, the supervision and inspection of related work to be clear: set up supervision and inspection of specific positions, personnel, clear job responsibilities. Usually take a regular, irregular combination of all staff to perform their duties, the implementation of the system documents to check the situation; the use of internal audits to carry out the whole element, the whole process of 'audit inspection, assessment of compliance with the system documents, the effectiveness of the system operation, on the discovery of non-compliance with the rectification recommendations, supervise the responsible departments according to the plan to implement the corrective and assessment of the effect of rectification.
Medical laboratories should focus on personnel, testing equipment, samples, methods, facilities and environment, testing records and other content of the focus of supervision and inspection, based on the content of the inspection to develop a flowchart and carry out one by one, to avoid missing items. Inspections are carried out in a combination of regular routine inspections and unscheduled spot checks, with functional managers and professional and technical personnel*** participating in the inspections to strengthen the understanding and awareness of the provisions of the system documents and the process management requirements at the same time. The person in charge of the laboratory from time to time to carry out random checks to ensure that the supervision and inspection does not leave a dead corner, to ensure that through the supervision and inspection of the system to promote the smooth progress of the work.
Third, the medical laboratory quality management system for continuous improvement
According to national regulations or relevant standards to establish a quality management system is an effective way to improve the level of management of medical laboratories, but only to establish is not enough, but also to ensure that the system operates effectively, and to make the quality management system to be continuously improved. Medical laboratories can only achieve continuous improvement to meet the requirements of service users. Continuous quality improvement can improve the quality and ability of medical laboratories, can make the quality management system more perfect, more effective operation. In short, continuous improvement is the intrinsic requirements of the quality management system of the medical laboratory, but also the fundamental guarantee of the sustainable development of the medical laboratory.
1. Steps for continuous improvement: medical laboratories in accordance with the requirements of the quality management system for the operation of the status quo analysis, review, evaluation, through the following steps to achieve continuous improvement of the quality management system: (1) collection of external information, identification of areas in need of improvement; (2) their own review, identification of projects to be improved; (3) to determine the goal of the improvement to find ways to solve the problem; (4) evaluation of measures to improve the effectiveness, to determine the effect of the improvement; (5) the quality management system is not only the quality management system, it is also the quality management system of the medical laboratory. Effectiveness, to determine the effect of improvement; (5) the development of quality indicators, systematic monitoring and evaluation.
2. Implementation of continuous improvement: (1) collect external information, identify areas for improvement: medical laboratories should pay attention to the improvement of suggestions and comments from the outside, which usually come from the service users, external inspection agencies, higher authorities, and so on. Service users usually give comments, suggestions or complaints to the medical laboratory from the perspective of satisfaction or expectation of the service received. The laboratory should arrange a person to be responsible for receiving, investigating, and dealing with these opinions and suggestions, and there should be a special procedure to deal with complaints [11]. Opinions or suggestions from external inspection organizations and authorities are usually conclusions about whether the laboratory work meets the laws, regulations or standards, and the laboratory should be corrected in accordance with the regulations and formulate effective measures to avoid the recurrence of the problem. For all kinds of information from the outside, the laboratory should attach great importance to, carefully analyze the reasons, identify the aspects that can be improved, and make timely and effective improvements, and incorporate them into the content of daily supervision and inspection to ensure continuous improvement. (2) through its own review, identify items that can be improved: internal audit and management review is a medical laboratory quality management system to achieve continuous improvement of the key work is very necessary, the effective implementation of internal audit and management review, for the quality management system to achieve continuous improvement is crucial. Internal audit is usually carried out after the quality management system has been established and run for a period of time. Internal audit is not less than 1 time per year, and the interval between 2 audits is not more than 12 months. Additional internal audits must be conducted in the following cases: major changes in the quality policy and quality objectives, organizational structure, major changes in the management system, medical accidents, major medical defects, continuous defects in a certain area by patients or clinical staff, relocation of important workplaces or changes in the environment, third-party audits, and expiration of the registration status of the accreditation of the medical laboratory. The internal auditor who conducts the internal audit work needs to be a person who has been trained in the knowledge and skills related to internal auditing and has been authorized by the laboratory director, and cannot audit the work of the department in which he/she works. Therefore, the laboratory should have a certain number of personnel capable of performing the work of internal auditors, whose training can be organized by the laboratory itself, and the training content should be in line with the relevant requirements of internal audit. Good internal audit planning for the effect of internal audit is critical, internal audit planning should be established on the basis of the laboratory system documents, in accordance with the system to carry out the actual implementation of the internal audit planning table design, in order to ensure that through the internal audit of the laboratory quality management system to make a systematic and objective evaluation of compliance, appropriateness and effectiveness. Management review is a formal evaluation of the current status and appropriateness of the quality management system by the top management of the laboratory on the quality policy and objectives, which is a comprehensive inspection of the quality management system. The purpose of the management review of the quality management system of the medical laboratory and all the medical services of the medical laboratory (including testing and consulting work) is to ensure that the quality of the service is maintained at a stable level in the clinical testing work and that the necessary changes or improvements are made in a timely manner. The results of the management review are documented, including the objectives of the medical laboratory for the next phase and the corresponding plans and measures, as well as the objectives and corresponding plans and measures for improvement in areas where problems or potential problems have occurred. Management review and the hospital routine year-end summary effectively combined together, not only can a comprehensive laboratory management system to summarize the work, but also can effectively reduce the material summary, declaration, meetings and other work frequency, so that the quality management system work and administrative management work organically unified, to achieve the true meaning of the total quality management system.
3. Evaluation of the effect of continuous improvement: medical laboratories through the assessment of the quality policy, quality objectives and the results of internal quality audits and other work to assess the quality management system operation and improve the effectiveness of the purpose. Focus on the assessment of the contents of the main: quality policy, quality objectives are appropriate and achieve the established goals; personnel training and competence assessment; internal audit results and the effect of rectification; patient service satisfaction. Regularly evaluate the implementation of the quality policy and the achievement of the quality objectives, not only to ensure that the annual quality objectives meet the expected set values, but also to pay attention to the achievement of each time period, pay attention to the existence of problems and correct them in a timely manner. Concerned about the ability of personnel and the work performed by the suitability of the job, can be competent? Formulate training programs for personnel in different positions and evaluate the training effect and individual comprehensive ability through various forms of assessment. Continuously pay attention to the rectification and maintenance of non-conformities issued by internal audit to ensure that the same non-conformities do not occur again. Monitoring and evaluating the quality and satisfaction of testing and consulting services provided by medical laboratories to patients and clinical staff in as objective a manner as possible [12].
Fourth, the role and significance of the quality management system of medical laboratories
Medical laboratories as the carrier of the development of the discipline of laboratory medicine, must be adjusted accordingly in the knowledge structure, talent structure, the direction of development of the discipline, quality management, etc. in order to show the development of the discipline, and ultimately to further promote the discipline's long-term development. In order to realize this goal, while having solid basic theory and operation skills, the overall quality management of medical laboratory should be strengthened. Review of China's medical laboratory, most of the introduction of advanced medical equipment, advanced laboratory technology, a large number of test technicians go abroad every year for further study, to participate in a variety of international conferences, but also a lot of overseas students to return to China, to join the ranks of the test medicine, but we and the advanced countries of the medical laboratory is still there is a certain gap, the reason is that we are in the management of medical laboratories and foreign countries there is a certain gap. The reason is that there is a gap between our medical laboratory management and that of foreign countries. Medical laboratories to clinical diagnosis and treatment to provide stable, reliable test results, must establish a comprehensive quality management system, the system is to ensure the quality of the core test.
1. Promote medical laboratories to improve the quality and ability of clinical testing: the quality and ability of clinical testing is a medical laboratory to meet the needs of service users of the external performance. The quality of service of medical laboratories not only involves the quality of work of its internal departments, but also depends on the close cooperation and a high degree of coordination between the departments. The construction of a quality management system provides guidance for coordinating the work among various departments of medical laboratories to better meet the needs of service users, and is of great practical significance in promoting medical laboratories to improve their service quality and capability. Through the construction of quality management system, it can improve the quality management level of medical laboratories, reduce the possible quality risks and the responsibility of the laboratory, balance the interests between the laboratory and the patient, and improve the trust of the community on the construction of quality management system of the laboratory.
2. Improve the core competitiveness of medical laboratories: any enterprise, no matter in which environment, will be very concerned about the quality of the product. In order to be successful, it is essential that its products meet the appropriately specified needs, uses or purposes, fulfill the expectations of the people it serves, comply with applicable standards and norms, and conform to societal requirements, including the obligations imposed by laws, codes, rules, regulations, and other matters. These goals above are summarized as good quality and good service. For medical laboratories to achieve this goal, a quality management system must be in place to achieve improved quality of service and competence. The establishment and effective operation of the quality management system is to ensure that the quality of service and capacity of the medical laboratory is an important basis, but also to win the trust of clinical care and patients favorable protection, to enhance the core competitiveness of the medical laboratory has an important guiding significance.
3. Promote the development of China's medical laboratory: from the current problems in China's laboratory medicine can be seen, the quality management of medical laboratories is its ability to achieve the development of the fundamental. Although some quality problems exist objectively and can not be avoided, but most of the quality problems can be controlled through effective management, and ultimately realize the laboratory's established quality goals. Through the construction of quality management system, the organizational structure and workflow of clinical testing service management have been further improved, and the key factors affecting the quality of clinical testing services have been clarified. For the promotion of testing staff to provide high-quality services, consciously and actively maintain and improve the quality of service of the medical laboratory provides an effective method and approach to promote the development of China's test medicine has an important reference and reference value.
V. Conclusion
Medical laboratories by summarizing the analysis of their own quality management in the many problems [13], and seriously from the historical development, objective conditions, their own ability to analyze the existence of many deficiencies in the reasons, focusing on the internal management of the existence of many deficiencies in the formation of the mechanism, focusing on the quality of management deficiencies proposed to solve the problem. Management of deficiencies in the proposed solutions. Medical laboratory to establish a quality management system, through careful planning and design, the organization of all staff education and training, so that each member of the concept of quality management system, purpose, methodology, based on the principles and standards have a full understanding of the quality management system, and at the same time to recognize the quality of the laboratory quality management of the status quo and the advanced management model of the differences between the significance of the establishment of a quality management system.
Through training and learning to raise awareness, unify thinking, and firm determination to establish a quality management system. Through a clear medical laboratory management system of quality policy and objectives, determine the organizational structure of the medical laboratory, clear and complete the allocation of resources, writing system documents and other steps to establish a quality management system. After document learning, process management, supervision and inspection, internal audit, management review and other work to ensure that the quality management system can operate smoothly, and ultimately realize the standardization of quality management work, and continue to improve the quality of testing services and capabilities of the purpose.
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